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The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetic Acid | Experimental | Topic application of a Acetic Acid 2% solution for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments |
|
| Control group | Active Comparator | Topic application of Prontosan® for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetic Acid | Drug | The intervention treatment will consist of cleaning with water and soap, application of a compress soaked in 2% dilution of glacial acetic acid (CAS 64-19-7) for 15 minutes, irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the ulcer bed. Depending on the amount of exudate, more or less alginate will be added as a secondary dressing. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment | The assessment of the ulcer will include measuring its area through digital planimetry. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with ulcer healing at 4 weeks from the start of treatment. | The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized. | 4 weeks |
| Percentage of participants with ulcer healing at 12 weeks from the start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Participants diagnosed with any of the following conditions:
Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta De Vicente | Contact | +34 9389316161 | mdevicente@csapg.cat | |
| NoemĂ Casaponsa | Contact | +34 938960025 | 43197 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| Marta De Vicente | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari Alt'Pènedes i Garraf | Recruiting | Barcelona | Catalonia | 08810 | Spain |
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
After publication of main results of the study.
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
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| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Prontosan | Drug | The treatment includes ulcer cleansing with water and soap, application of ProntosanⓇ compress for 15 minutes, subsequent irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the wound bed. More or less alginate will be applied depending on the amount of exudate. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion. |
|
|
The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized. |
| 12 weeks |
| Time (days) to ulcer healing from the start of treatment. | The lesion will be considered fully healed when the surface is epithelialized. This will be confirmed by the nurse responsible for monitoring the lesion. | up to 12 weeks |
| Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. | The evaluation of changes will be conducted by a trained nurse to apply the RESVECH 2.0 scale. The scores in Section 6 of the RESVECH scale range from 0 to 14. The higher the score, the greater the severity of the injury. | 8 weeks |
| Number of adverse reactions associated with the treatment, collected from the medical record. | The number of adverse reactions will be evaluated through the review of the participant's medical records by a trained member of the research team. | 12 weeks |
| The healthcare expenditure associated with each branch of the study | A descriptive analysis of healthcare expenditure associated with each study branch will be conducted using billing data from the center, which is linked to the insured individual's resource utilization. | 12 weeks |
| Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment | The assessment of the ulcer will include measuring its area through digital planimetry. | 4 weeks |
| Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment | The assessment of the ulcer will include measuring its area through digital planimetry. | 12 weeks |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |